Evaluating Right Ventricular (RV) Size and Function Using the Upper Valley RV Algorithm and Novel Imaging Modalities

Acute Coronary Syndrome Clinical Trial

— UVRV  

Official title:

A Single-Center, Blinded, Randomized Control Trial Evaluating Different Approaches to Evaluation of Right Ventricular Size and Function Using the Upper Valley Right Ventricle Algorithm and Novel Imaging Modalities

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03935178
• Other study ID #: D19082 HVC 2019
• Status: Terminated
• Start date: August 5, 2019
• Est. completion date: January 30, 2022

Study information

• Verified date: March 2022
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary purpose of this study is to evaluate the diagnostic performance of three methods for measuring right ventricular size and function including the Philips Novel RV quantification technologies (RV Heart Model volumetric analysis and Philips 2D strain) and the Upper Valley Right Ventricle Algorithm (UVRV) algorithm as compared to the gold standard of volumetric analysis via cardiac magnetic resonance imaging (CMR) in a broad patient population.

Description:

This is a single-center, blinded, randomized control trial of patients 18-years or older that are undergoing CMR as a standard of care at Dartmouth-Hitchcock Medical Center in Lebanon, NH. After informed consent is obtained, subjects undergo a study-specific external, non-invasive echocardiogram utilizing a special RV focused protocol on the same day of their CMR as close to their scheduled CMR as possible to minimize wait time for consented patients. The echocardiogram takes approximately an additional 30 minutes of the subject's time. De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three different methodologies (standard method, Phillips Novel technology and the newly developed UVRV algorithm). The methodologies will be compared with each other to determine sensitivity, specificity and accuracy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: January 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient age is over 18 years
• Patient is undergoing Cardiac MRI with sequences that permit biventricular volumetric analysis
• Patient is capable of giving informed consent
• The cardiac MRI images are of diagnostic quality to provide accurate RV and LV volumes

Exclusion Criteria:

• Patient unable to under echocardiogram

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Congenital Heart Disease
• Congestive Heart Failure
• Embolism
• Heart Defects, Congenital
• Heart Diseases
• Heart Failure
• Heart Valve Diseases
• Hypertension, Pulmonary
• Pulmonary Embolism
• Pulmonary Hypertension
• Valvular Heart Disease

Intervention

Diagnostic Test:
• Measuring Right Ventricular Size and Function
This study focuses on evaluating different approaches to evaluation of right ventricular size and function using the Upper Valley Right Ventricle Algorithm and novel imaging modalities

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Echocardiographic measurement - Right ventricular size	De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies. Specific evaluating MRI derived right ventricular volumes versus various echo approaches to grading right ventricular size.	Echocardiographic measurements are taken on the same day as the scheduled CMR, as close to the scheduled CMR as possible, approximately 1 hour
Primary	Echocardiographic measurement - Right ventricular function	De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies.	Echocardiographic measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour
Primary	Echocardiographic measurement - Right ventricular dysfunction severity	De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies. Severity reported as mild, moderate or severe)	Echocardiographic measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour